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FDA OKs First Drug-Coated Balloon for In-Stent Restenosis
The US Food and Drug Administration (FDA) has approved Boston Scientific's Agent Drug-Coated Balloon (DCB), the first coronary DCB for the treatment of coronary in-stent restenosis in patients with coronary artery disease, the company has announced in a news release.
In-stent restenosis makes up an estimated 10% of percutaneous coronary interventions in the United States.
The Agent DCB is a paclitaxel-coated balloon catheter that transfers a therapeutic dose of the antiproliferative drug to the vessel wall to help prevent in-stent restenosis reoccurrence.
The FDA granted the Agent DCB breakthrough device designation in 2021. It approved the device in part based on results from the AGENT IDE trial.
Conducted at 40 sites in the United States, the trial randomly assigned patients with coronary artery in-stent restenosis to the Agent DCB or to conventional balloon angioplasty.
In the prespecified interim analysis of the first 480 patients enrolled, the study met the primary endpoint of target lesion failure at 12 months, with the Agent DCB superior to uncoated balloon angioplasty (17.9% vs 28.7%; P = .006).
"This represented a 38% relative risk reduction as well as a 10% absolute risk reduction in the endpoint," principal investigator Robert Yeh, MD, of Beth Israel Deaconess Medical Center in Boston, reported at the Transcatheter Cardiovascular Therapeutics 2023 Congress.
Findings also included zero definite/probable cases of stent thrombosis (0.0% vs 3.9%; P = .001), a 49% risk reduction in target-vessel related myocardial infarction (6.4% vs 12.3%; P = .03) and low adverse event rates at 12 months, Boston Scientific noted in the news release.
"The Agent IDE trial demonstrated that the Agent DCB is an effective and safe treatment option for coronary in-stent restenosis, even in a high-risk population, which included many individuals with multi-layer stents or diabetes," Yeh added in the release.
"Treating in-stent restenosis has been challenging in the U.S. with limited therapies available, and this new technology will help physicians reduce the risk of restenosis without radiation or introducing additional metal layers, which do not provide an adequate result for some patients," Yeh said.
Boston Scientific plans to launch the Agent DCB in the United States in the coming months. It's already available in Europe, parts of Asia Pacific, and Latin America.
